UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054214 |
|---|---|
| Receipt number | R000061547 |
| Scientific Title | Quantifying Brain Oxygenation Index for Thrombectomy Outcome Assessment Study |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2024/04/22 00:05:53 |
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Basic information
Public title
Quantifying Brain Oxygenation Index for Thrombectomy Outcome Assessment Study
Acronym
Q-BOT study
Scientific Title
Quantifying Brain Oxygenation Index for Thrombectomy Outcome Assessment Study
Scientific Title:Acronym
Q-BOT study
Region
| Japan |
Condition
Condition
Patients undergoing endovascular reperfusion therapy for cerebral infarction due to acute occlusion of the main cerebral artery (internal carotid artery or middle cerebral artery)
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among the evaluation of cerebral oxygenation indices by time-resolved-near-infrared spectroscopy (TD-NIRS) devices in routine medical care, this study targets cases that are measured before and after endovascular reperfusion therapy for cerebral infarction due to acute occlusion of the main cerebral artery, and aims to establish tissue reperfusion indices at the peripheral level of the brain before and after surgery
Basic objectives2
Others
Basic objectives -Others
Whether TD-NIRS can assess peripheral brain tissue perfusion status in acute reperfusion thepray
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between TD-NIRS measurements and cases of functional independence (modified Rankin Scale 0-2) after 3 months in effective reperfusion cases
Key secondary outcomes
Relationship between TD-NIRS measurements and
Preoperative ischemia severity (NIHSS)
Ischemic core volume and penumbra volume and their ratio on preoperative CT perfusion imaging
Percentage of good collateral perfusion on preoperative CT angiography and cerebral angiography
Degree of reperfusion (expanded TICI grade) and presence of early venous drainage on cerebral angiography at the end of the procedure
Number of procedures performed in patients with complete reperfusion on cerebral angiography
Ischemic core volume and penumbra volume and their ratios in the immediate postoperative CT perfusion images
Infarct expansion within 24 hours after surgery
Symptomatic intracranial hemorrhage within 24 hours after surgery
Early improvement of neurological symptoms within 24 hours after surgery
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who satisfy the following (1) to (6)
(1) Patients who undergo endovascular reperfusion therapy within 24 hours of onset for cerebral infarction caused by occlusion of the main artery (internal carotid artery or middle cerebral artery M1, M2, or beyond)
(2) TD-NIRS measurement is performed in the usual medical examination
(3) 18 years of age or older
(4) Independent in daily life before onset (mRS 2 or less)
(5) Cerebral infarction severity at presentation with NIHSS > 4
(6) Patients who have obtained written consent from the patient or a surrogarate
Key exclusion criteria
Patients who satisfy the following (1) or (2)
(1) Patients who are currently participating in another clinical trial
(2) Patients who are judged by the physician to be unsuitable for the clinical trial
(3) Pregnant patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Hashimoto |
Organization
Kyoto Prefectural University of Medicine
Division name
Neurosurgery
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokouji, Kamigyo-ku, Kyoto
TEL
075-251-5541
nhashimo@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Maruyama |
Organization
Kyoto Prefectural University of Medicine
Division name
Neurosurgery
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokouji, Kamigyo-ku, Kyoto
TEL
075-251-5541
Homepage URL
dmaruyam@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Health Management Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Hospital Organization Maizuru Medical Center, Japanese Red Cross Kyoto Daini Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB center Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-Hirokouji, Kamigyo-ku, Kyoto
Tel
0752515337
rinri@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都府立医科大学附属病院（京都府）、国立病院機構 舞鶴医療センター（京都府）、京都第二赤十字病院（京都府r）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational study.
This is an observational study based on routine medical care, and the examination items and frequency are the same as those in routine medical care. Participation in this study is not considered burdensome or risky.
Management information
Registered date
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061547
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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